Tissue processing device with ultrasonic tissue particle separator

ABSTRACT

A device is operable to separate tissue particles. The device comprises a reservoir and an ultrasonic transducer. The reservoir is configured to receive tissue particles in a fluid. The ultrasonic transducer is operable to emit ultrasonic energy toward tissue particles in the reservoir. Control circuitry is configured to drive the ultrasonic transducer at parameters selected to provide movement of tissue particles in the first reservoir based on the size of the tissue particles. The ultrasonic transducer may thus drive the tissue particles toward respective outlets or at particular times based on their particle size. An electrically driven screen may be used to separate tissue particles from liquid. An ultrasonic mincing device may be used to mince tissue particles whose size exceeds a predetermined size range.

BACKGROUND

Fistulae can occur for a variety of reasons, such as, from a congenitaldefect, as a result of inflammatory bowel disease such as Crohn'sdisease, some sort of trauma, or as a side effect from a surgicalprocedure. Additionally, several different types of fistulae can occurin humans, for example, urethro-vaginal fistulae, vesico-vaginalfistulae, tracheo-esophageal fistulae, gastrointestinal fistulae, forexample gastrocutaneous, enterocutaneous and colocutaneous fistulae, andany number of anorectal fistulae such as recto-vaginal fistula,recto-vesical fistulae, recto-urethral fistulae, and recto-prostaticfistulae. When fistulas form, they can track between intestinal segmentsor between an intestinal segment and other organs (e.g., bladder,vagina, etc.), adjacent tissue, or the skin. Fistulas are classified asinternal when they communicate with adjacent organs (e.g.,entero-enteric and rectovaginal fistulas, etc.) and external when theycommunicate with the dermal surface (e.g., enterocutaneous, peristomaland perianal fistulas, etc.).

Promoting and improving tissue healing around the fistula opening and inthe fistula tract may be an important aspect of fistulae medicaltreatments. For instance, promoting and improving tissue healing maylead to quicker recovery times and lessen the opportunity for infection,particularly in a post-surgical context. Some advancements in themedical arts pertaining to systems, methods, and devices to promote andimprove tissue healing in patients aim to add active biologicalcomponents (e.g., tissue particles, stem cells, other types of cells,etc.) to a wound site (e.g., surgical site, accidental trauma site,etc.) or other defect site (e.g., caused by disease or other condition,etc.) to promote tissue regeneration or accelerate tissue healing. Whenadding biological components to a site, such components may be addedindependently or as part of a specifically designed matrix or othermixture depending on the condition being treated and goals of thetreatment. Some examples of cell-based therapy technology are disclosedin U.S. Pub. No. 2008/0311219, entitled “Tissue Fragment Compositionsfor the Treatment of Incontinence,” published Dec. 18, 2008, thedisclosure of which is incorporated by reference herein. Additionalexamples of cell-based therapy technology are disclosed in U.S. Pub. No.2004/0078090, entitled “Biocompatible Scaffolds with Tissue Fragments,”published Apr. 22, 2004, the disclosure of which is incorporated byreference herein. Additional examples of cell-based therapy technologyare disclosed in U.S. Pub. No. 2008/0071385, entitled “ConformableTissue Repair Implant Capable of Injection Delivery,” published Mar. 20,2008, the disclosure of which is incorporated by reference herein.

Regardless of how the active biological components are delivered orapplied to a site, the biological components must first be obtained andprepared. One approach for obtaining such biological components is toharvest the desired components from a healthy tissue specimen (e.g., inan adult human). Examples of devices and associated methods forcollecting and processing harvested tissue are disclosed in U.S. Pub.No. 2004/0193071, entitled “Tissue Collection Device and Methods,”published Sep. 30, 2004, the disclosure of which is incorporated byreference herein. Additional examples of devices and associated methodsfor collecting and processing harvested tissue are disclosed in U.S.Pub. No. 2005/0038520, entitled “Method and Apparatus for Resurfacing anArticular Surface,” published Feb. 17, 2005, the disclosure of which isincorporated by reference herein. Additional examples of devices andassociated methods for collecting and processing harvested tissue aredisclosed in U.S. Pat. No. 7,611,473, entitled “Tissue Extraction andMaceration Device,” issued Nov. 3, 2009, the disclosure of which isincorporated by reference herein. Additional examples of devices andassociated methods for collecting and processing harvested tissue aredisclosed in U.S. Pub. No. 2008/0234715, entitled “Tissue Extraction andCollection Device,” published Sep. 25, 2008, the disclosure of which isincorporated by reference herein. Additional examples of devices andassociated methods for processing harvested tissue are disclosed in U.S.Pub. No. 2005/0125077, entitled “Viable Tissue Repair Implants andMethods of Use,” published Jun. 9, 2005, the disclosure of which isincorporated by reference herein. Additional examples of devices andassociated methods for collecting and processing harvested tissue aredisclosed in U.S. Pat. No. 5,694,951, entitled “Method for TissueRemoval and Transplantation,” issued Dec. 9, 1997, the disclosure ofwhich is incorporated by reference herein. Additional examples ofdevices and associated methods for collecting and processing harvestedtissue are disclosed in U.S. Pat. No. 6,990,982, entitled “Method forHarvesting and Processing Cells from Tissue Fragments,” issued Jan. 31,2006, the disclosure of which is incorporated by reference herein.Additional examples of devices and associated methods for collecting andprocessing harvested tissue are disclosed in U.S. Pat. No. 7,115,100,entitled “Tissue Biopsy and Processing Device,” issued Oct. 3, 2006, thedisclosure of which is incorporated by reference herein.

Once harvested and suitably processed (e.g., incorporated with ascaffold, etc.), biological material such as tissue fragments may beapplied to a wound site or other type of site within the human body in avariety of ways. Various methods and devices for applying suchbiological material are disclosed in one or more of the U.S. patentreferences cited above. Additional methods and devices for applying suchbiological material are disclosed in U.S. Pub. No. 2005/0113736,entitled “Arthroscopic Tissue Scaffold Delivery Device,” published May26, 2005, the disclosure of which is incorporated by reference herein.

While a variety of devices and techniques may exist for harvesting,processing, and applying biological components from a tissue specimen,it is believed that no one prior to the inventor(s) has made or used aninvention as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings. Inthe drawings, like numerals represent like elements throughout theseveral views.

FIG. 1 depicts a diagrammatic view of an exemplary tissue processingsystem.

FIG. 2 depicts a perspective view of optional components of the tissueprocessing system of FIG. 1.

FIG. 3 depicts a perspective view of an exemplary tissue harvestingdevice of the tissue processing system of FIG. 1.

FIG. 4A depicts a partial view of a port of the tissue harvesting deviceof FIG. 3 separated from a port of a console of the tissue processingsystem of FIG. 1.

FIG. 4B depicts a partial view of the ports of FIG. 4A coupled together.

FIG. 5 depicts a perspective view of an exemplary console of the tissueprocessing system of FIG. 1.

FIG. 6 depicts a perspective view of exemplary tissue processingcomponents of the console of FIG. 5, with the console housing shown inbroken lines.

FIG. 7 depicts a perspective view of an exemplary ultrasonic tissuemeasuring chamber of the console of FIG. 5.

FIG. 8 depicts a perspective view of an exemplary alternative ultrasonictissue measuring chamber of the console of FIG. 5.

FIG. 9 depicts a side view of an ultrasonic tissue measuring chambermounted at a non-horizontal angle.

FIG. 10 depicts a side cross-sectional view of an exemplary stirringchamber of the console of FIG. 5.

FIG. 11 depicts a schematic view of another exemplary alternativeultrasonic tissue measuring chamber of the console of FIG. 5.

FIG. 12 depicts a perspective view of an exemplary fluid removal chamberof the console of FIG. 5.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples should not be used tolimit the scope of the present invention. Other features, aspects, andadvantages of the versions disclosed herein will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out theinvention. As will be realized, the versions described herein arecapable of other different and obvious aspects, all without departingfrom the invention. Accordingly, the drawings and descriptions should beregarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Treatment Compositions, Devices, and Methods

Examples described herein include devices that are operable to harvesttissue, mince or morcellate tissue, mix tissue particles with othermedical fluid components, and/or dispense a medical fluid at a targetsite in a patient. As described in greater detail below, the medicalfluid may include any of a variety of biocompatible materials thataccelerate tissue healing, promote tissue regeneration, and/or provideother results. As used herein, the terms “tissue treatment composition,”“tissue repair composition,” and “medical fluid” should be readinterchangeably. It should also be understood that a tissue treatmentcomposition or medical fluid as referred to herein may have any suitableconsistency, including but not limited to the consistency of a slurry.

A medical fluid as referred to herein may be derived from anybiocompatible material, including but not limited to synthetic ornatural polymers. The consistency of the medical fluid may be viscous,or gel-like, that of a slurry composed of microparticles, or any othersuitable consistency. By way of example only, any fluid consistency thatmay permit injection through a catheter may be used. The medical fluidmay also provide adhesive characteristics, such that once it is injectedat a target site (e.g., into a fistula), the fluid coagulates or gels(e.g., allowing for a plug to be retained within a fistula). The medicalfluid of the present example is also able to support cell migration andproliferation such that healing at a target site in a patient can occur.The fluid is suitable to be mixed with biological materials. Examples ofmedical fluid components include but are not limited to thrombin,platelet poor plasma (PPP) platelet rich plasma (PRP), starch, chitosan,alginate, fibrin, polysaccharide, cellulose, collagen,gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-basedadhesive, poly (amino acid), agarose, amylose, hyaluronan,polyhydroxybutyrate (PHB), hyaluronic acid, poly(vinyl pyrrolidone)(PVP), poly(vinyl alcohol) (PVA), polylactide (PLA), polyglycolide(PGA), polycaprolactone (PCL), and their copolymers, VICRYL® (Ethicon,Inc., Somerville, N.J.), MONOCRYL material, PANACRYL (Ethicon, Inc.,Somerville, N.J.), and/or any other material suitable to be mixed withbiological material and introduced to a wound or defect site, includingcombinations of materials. Other suitable compounds, materials,substances, etc., that may be used in a medical fluid will be apparentto those of ordinary skill in the art in view of the teachings herein.

By way of example only, one or more components in a medical fluid ortissue treatment composition may comprise at least one viable tissuefragment having one or more viable cells that, once applied, canproliferate and integrate with tissue at a target site in a patient. Forinstance, viable cells may migrate out of a tissue particle and populatea scaffold material, which may be positioned at a target site in apatient. Such tissue fragments may have been harvested from the samepatient in whom they are reapplied; or may have been harvested fromanother person or source. The tissue fragments may comprise autogenictissue, allogenic tissue, xenogenic tissue, mixtures of any of theforegoing, and/or any other type(s) of tissue. The tissue fragments mayinclude, for example, one or more of the following tissues or tissuecomponents: stem cells, cartilage tissue, meniscal tissue, ligamenttissue, tendon tissue, skin tissue, muscle tissue (e.g., from thepatient's thigh, etc.), periosteal tissue, pericardial tissue, synovialtissue, fat tissue, bone marrow, bladder tissue, umbilical tissue,embryonic tissue, vascular tissue, blood and combinations thereof. Ofcourse, any other suitable type of tissue may be used, including anysuitable combination of tissue types. In some versions, the type oftissue used is selected from a tissue type most resembling the tissueat, near, or surrounding the target site (e.g., fistula, etc.).

Tissue for providing at least one viable tissue fragment may be obtainedusing any of a variety of tissue biopsy devices or using other types oftissue harvesting devices or techniques. Exemplary biopsy devicesinclude those taught in U.S. Pat. No. 5,526,822, entitled “Method andApparatus for Automated Biopsy and Collection of Soft Tissue,” issuedJun. 18, 1996; U.S. Pat. No. 6,086,544, entitled “Control Apparatus foran Automated Surgical Biopsy Device,” issued Jul. 11, 2000; U.S. Pub.No. 2007/0118048, entitled “Remote Thumbwheel for a Surgical BiopsyDevice,” published May 24, 2007; U.S. Pub. No. 2008/0214955, entitled“Presentation of Biopsy Sample by Biopsy Device,” published Sep. 4,2008; U.S. Non-Provisional patent application Ser. No. 12/337,942,entitled “Biopsy Device with Central Thumbwheel,” filed Dec. 18, 2008;and U.S. Non-Provisional patent application Ser. No. 12/483,305,entitled “Tetherless Biopsy Device with Reusable Portion,” filed Jun.12, 2009. The disclosure of each of the above-cited U.S. patents, U.S.Patent Application Publications, and U.S. Non-Provisional PatentApplications is incorporated by reference herein. Such biopsy devicesmay be used to extract a plurality of tissue specimens from one or moresites in a single patient. It should also be understood that anysuitable device described in any other reference that is cited hereinmay be used to harvest tissue. Additional examples of devices that maybe used to harvest tissue will be described in greater detail below.Other examples will be apparent to those of ordinary skill in the art inview of the teachings herein. Tissue harvesting sites may include thesame sites in which tissue is reapplied as part of a treatment. Inaddition or in the alternative, tissue may be harvested from one siteand then reapplied at some other site as part of a treatment. In someversions, the tissue is reapplied in the same patient from whom thetissue was originally harvested. In some other versions, the tissue isapplied in a patient who is different from the patient from whom thetissue was originally harvested.

A tissue specimen may be obtained under aseptic conditions, and thenprocessed under sterile conditions to create a suspension having atleast one minced, or finely divided, tissue fragment. In other words,harvested tissue may be diced, minced or morcellated, and/or otherwiseprocessed. Harvested tissue specimens may be minced and otherwiseprocessed in any of a variety of ways. For instance, examples of tissuemincing and processing are described in U.S. Pub. No. 2004/0078090, thedisclosure of which is incorporated by reference herein. Alternatively,merely exemplary non-conventional devices and techniques that may beused to mince and process tissue will be described in greater detailbelow, while other examples will be apparent to those of ordinary skillin the art in view of the teachings herein. In order to ensure viabilityof the tissue, agitators or other features of a mincing and/or mixingdevice may be designed to sever and mix (rather than crush or compress)the tissue. In some settings, tissue specimens may be minced and/ormixed in a standard cell culture medium, either in the presence orabsence of serum. Tissue fragments may also be contacted with amatrix-digesting enzyme to facilitate cell migration out of anextracellular matrix surrounding the cells. Suitable matrix-digestingenzymes that may be used in some settings include, but are not limitedto, collagenase, chondroitinase, trypsin, elastase, hyaluronidase,peptidase, thermolysin, and protease. The size of each tissue fragmentmay vary depending on the target location, method for delivering thetreatment composition to the target site, and/or based on various otherconsiderations. For example, the tissue fragment size may be chosen toenhance the ability of regenerative cells (e.g., fibroblasts) in thetissue fragments to migrate out of the tissue fragments, and/or to limitor prevent the destruction of cell integrity. In some settings, idealtissue fragments are between approximately 200 microns and approximately500 microns in size. As another merely illustrative example, idealtissue fragments may be sized within the range of approximately 0.05 mm³and approximately 2 mm³; or more particularly between approximately 0.05mm³ and approximately 1 mm³. Of course, various other tissue fragmentsizes may be ideal in various different settings.

In some versions, a medical fluid may comprise minced tissue fragmentssuspended in a biocompatible carrier. Suitable carriers may include, forexample, a physiological buffer solution, a flowable gel solution,saline, and water. In the case of gel solutions, the tissue repaircomposition may be in a flowable gel form prior to delivery at thetarget site, or may form a gel and remain in place after delivery at thetarget site. Flowable gel solutions may comprise one or more gellingmaterials with or without added water, saline, or a physiological buffersolution. Suitable gelling materials include biological and syntheticmaterials. Exemplary gelling materials include the following: proteinssuch as collagen, collagen gel, elastin, thrombin, fibronectin, gelatin,fibrin, tropoelastin, polypeptides, laminin, proteoglycans, fibrin glue,fibrin clot, platelet rich plasma (PRP) clot, platelet poor plasma (PPP)clot, self-assembling peptide hydrogels, Matrigel or atelocollagen;polysaccharides such as pectin, cellulose, oxidized regeneratedcellulose, chitin, chitosan, agarose, or hyaluronic acid;polynucleotides such as ribonucleic acids or deoxyribonucleic acids;other materials such as alginate, cross-linked alginate,poly(N-isopropylacrylamide), poly(oxyalkylene), copolymers ofpoly(ethylene oxide)-poly(propylene oxide), poly(vinyl alcohol),polyacrylate, or monostearoyl glycerol co-Succinate/polyethylene glycol(MGSA/PEG) copolymers; and combinations of any of the foregoing. Inaddition to providing a flowable carrier solution for tissue fragments,a gelling agent(s) may also act as an adhesive that anchors the tissuerepair composition at the target site. In some versions, an additionaladhesive anchoring agent may be included in the tissue repaircomposition or medical fluid. Also, one or more cross-linking agents maybe used in conjunction with one or more gelling agents in order tocross-link the gelling agent.

The concentration of tissue fragments in a carrier and/or one or moremedical fluid components may vary depending on the target site location,method for delivering the treatment composition to the target site,and/or for various other reasons. By way of example, the ratio of tissuefragments to carrier (by volume) may be in the range of about 2:1 toabout 6:1, or in the range of about 2:1 to about 3:1. The medical fluidmay also include one more additional healing agents, such as biologicalcomponents that accelerate healing and/or tissue regeneration. Suchbiological components may include, for example, growth factors,proteins, peptides, antibodies, enzymes, platelets, glycoproteins,hormones, cytokines, glycosaminoglycans, nucleic acids, analgesics,viruses, isolated cells, or combinations thereof. The medical fluid mayfurther include one or more additional treatment components that preventinfection, reduce inflammation, prevent or minimize adhesion formation,and/or suppress the immune system. In some versions where a scaffold isused in conjunction with a tissue treatment composition, one or more ofthese additional biological components or additional treatmentcomponents may be provided on and/or within the scaffold. Similarly, insome versions where a scaffold plug is used in conjunction with a tissuerepair composition, one or more of these additional biologicalcomponents or additional treatment components may be provided on and/orwithin the scaffold plug. Some examples described herein may alsoinclude one or more adhesive agents in conjunction with viable tissuefragments.

As noted above, the harvested tissue may be combined with a scaffoldmaterial and/or other substances as part of a medical fluid, asdescribed herein, for administration to the patient. To the extent thattissue is incorporated with a scaffold material, it should be understoodthat any suitable material or combination of materials may be used toprovide a scaffold. By way of example only, scaffold material mayinclude a natural material, a synthetic material, a bioabsorbablepolymer, a non-woven polymer, other types of polymers, and/or othertypes of materials or combinations of materials. Examples of suitablebiocompatible materials include starch, chitosan, cellulose, agarose,amylose, lignin, hyaluronan, alginate, hyaluronic acid, fibrin glue,fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, plateletrich plasma (PRP) gel, platelet poor plasma (PPP) gel, Matrigel,Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerolco-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin,elastin, proteoglycans, polyhydroxybutyrate (PHB), polyvinylpyrrolidone) (PVP), polylactide (PLA), polyglycolide (PGA),polycaprolactone (PCL), and their copolymers, non-woven VICRYL®(Ethicon, Inc., Somerville, N.J.), MONOCRYL material, fibrin, non-wovenpoly-L-lactide, and non-woven PANACRYL (Ethicon, Inc., Somerville,N.J.). Polymers may include aliphatic polyesters, poly(amino acids),copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosinederived polycarbonates, poly(iminocarbonates), polyorthoesters,polyoxaesters, polyamidoesters, polyoxaesters containing amine groups,poly(anhydrides), polyphosphazenes, poly(propylene fumarate),polyurethane, poly(ester urethane), poly(ether urethane), and blends andcopolymers thereof. Suitable synthetic polymers for use in examplesdescribed herein may also include biosynthetic polymers based onsequences found in collagen, laminin, glycosaminoglycans, elastin,thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate,pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin,hyaluronic acid, silk, ribonucleic acids, deoxyribonucleic acids,polypeptides, proteins, polysaccharides, polynucleotides, andcombinations thereof. Other suitable materials or combinations ofmaterials that may be used will be apparent to those of ordinary skillin the art in view of the teachings herein. It should also be understoodthat tissue mixed with a scaffold material may have any suitableparticle size, and that the resulting mixture may at least initiallyhave the consistency of a slurry or have any other suitable consistency.In some versions, the tissue particles include an effective amount ofviable cells that can migrate out of the tissue particle and populatethe scaffold. The term “viable,” as used herein, should be understood toinclude a tissue sample having one or more viable cells.

In some versions, one or more components in a medical fluid or tissuetreatment composition comprise one or more healing agents that promotetissue regeneration at a target site (e.g., within a fistula) and/oraccelerate tissue healing at the target site. Healing agents may includeany of a variety of biocompatible materials that accelerate tissuehealing and/or promote tissue regeneration. Such biological componentsmay include, for example, growth factors, proteins, peptides,antibodies, enzymes, platelets, glycoproteins, hormones, cytokines,glycosaminoglycans, nucleic acids, analgesics, viruses, isolated cells,or combinations thereof. The medical fluid may further include one ormore additional treatment components that prevent infection, reduceinflammation, prevent or minimize adhesion formation, and/or suppressthe immune system. In some versions where a scaffold is used inconjunction with a tissue treatment composition, one or more of theseadditional biological components or additional treatment components maybe provided on and/or within the scaffold. Some examples describedherein may also include one or more adhesive agents in conjunction withviable tissue fragments.

Examples described herein relate to the repair (e.g., closing) of lumensin a patient, such as anal fistulas and other types of fistulas. Inparticular, examples described herein include devices used in at leastpart of a process to create and/or deliver tissue repair compositions ormedical fluid into a lumen such as an anal fistula. It should beunderstood that anal fistulas and/or other types of fistulas may berelatively difficult to repair (e.g., close) in some settings. The goalof a surgical repair of an anal fistula may be to close the fistula withas little impact as possible on the sphincter muscles. In some settings,a tissue repair composition or medical fluid as described herein may bedelivered into the fistula as a liquid composition, a flowable gel orpaste, a scaffold plug, or a combination of the two or more of theforegoing (e.g., a porous scaffold plug loaded with a medical fluidcomposition, etc). Anal fistulas may also be repaired by injectingbioresorbable fibrin glue into the fistula that seals the fistula andpromotes tissue growth across the fistula in order to provide permanentclosure. Various bioresorbable plugs may also be used to repair analfistulas. The plug may comprise, for example, collagen protein, tissue,stem cells, and/or other medical fluid components referred to herein;and the plug may be inserted into the fistula where it promotes tissuegrowth across the fistula as the plug dissolves. If desired, the plugmay be secured in place using one or more fasteners and/or one or moreadhesive agents. As another merely illustrative example, a medical fluidmay be introduced within the fistula, and the medical fluid mayeventually harden and then dissolve and/or be absorbed.

Prior to applying a medical fluid to a fistula, it may be desirable insome settings to debride the wall of a fistula (e.g., to removeepithelial cells, etc.), otherwise agitate the wall of the fistula,and/or otherwise treat the walls of the fistula. While examples hereinare discussed in the context of an anorectal fistula, it should beunderstood that the following exemplary devices and techniques may bereadily applied to various other types of fistulae. Similarly, while thepresent example relates to treatment of a fistula in a patient, itshould also be understood that the following exemplary devices andtechniques may be readily applied with respect to various other types ofconditions in a patient. Other suitable ways in which the devices andtechniques described herein may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

In some settings, a single device may be used to mince and mix tissuefrom a patient to form a medical fluid or later be incorporated in amedical fluid. Another device may be used to administer the medicalfluid to the patient. In some instances, the device that is used toadminister the medical fluid may be the same device that was used toinitially harvest the tissue from the patient. Various examples ofdevices that may perform at least some of these functions will bedescribed in greater detail below, while other examples will be apparentto those of ordinary skill in the art in view of the teachings herein.

As used herein, the term “fluid communication” (or in some contexts“communication”) means that there is a path or route through which fluid(gas, liquid or other flowable material) may flow between twocomponents, either directly or through one or more intermediatecomponents. Similarly, the term “conduit” encompasses a conduit withinor integrated with a valve. In other words, fluid communication betweentwo components means that fluid can flow from one component to anotherbut does not exclude an intermediate component (e.g., a valve, etc.)between the two recited components that are in fluid communication.Similarly, two or more components may be in mechanical “communication”with each other even if intermediate components are interposed betweenthose two or more components.

II. Overview of Exemplary Tissue Processing System

FIG. 1 shows various components of an exemplary tissue processing system(10). Each component of tissue processing system (10) will be describedin greater detail below. It should be understood, however, that thecomponents of tissue processing system (10) described below are mereexamples. Each component may be varied in numerous ways as will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, each component may be substituted, supplemented, oreven omitted as desired. It should also be understood that thearrangement of components shown in FIG. 1 is merely illustrative; andthat such components (and/or other components) may be provided in anyother suitable arrangements. In the present example, tissue processingsystem (10) comprises a tissue harvesting device (100) and a console(200). As shown in FIGS. 1-2, tissue harvesting device (100) isconfigured to removably couple with console (200). In particular, and aswill be described in greater detail below, tissue harvesting (100)device is operable to transmit harvested tissue specimens to console(200). Console (200) is then operable to process tissue specimens, andtransmit the processed tissue back to tissue harvesting device (100) forsubsequent administration to a patient.

As can be best seen in FIG. 1, console (200) of the present examplecomprises a tissue stirring chamber (300), which is operable to stirtissue transmitted from tissue harvesting device (100). Console (200)further comprises an ultrasonic tissue measuring chamber (400), whichreceives stirred tissue from tissue stirring chamber (300). If warrantedby the size of tissue particles in ultrasonic tissue measuring chamber(400), tissue particles may be communicated to tissue mincing chamber(500), which is in communication with tissue measuring chamber (400),and which may transmit minced tissue back to tissue measuring chamber(400). Tissue particles having a suitable size are ultimatelytransmitted from tissue measuring chamber (400) to a stimulation chamber(600). Other, undesirable tissue particles are transmitted from tissuemeasuring chamber (400) to a waste chamber (700). After suitable tissueparticles are sufficiently stimulated in stimulation chamber (600), thetissue particles proceed to a fluid removal chamber (800), where atleast some fluid is removed from the tissue particles. At this stage, atleast some tissue particles may be transmitted to waste chamber (700).In addition or in the alternative, at least some tissue particles may betransmitted to a tissue container (900). In some versions, at least sometissue particles may be transmitted back to tissue harvesting device(100). Fluid removed by fluid removal chamber (800) is transmitted to afluid reservoir (1000). Fluid reservoir (1000) is also in communicationwith tissue stirring chamber (300), such that fluid removed by fluidremoval chamber (800) may be re-used in a subsequent process of stirringtissue.

Console (200) further includes a fluid pump (1110), which may be used toflush tissue from tissue harvesting device (100) and/or otherwisecommunicate fluid within system (10). Fluid pump (1110) may comprise agear pump, peristaltic pump, diaphragm pump, positive displacement pump,or any other suitable type of pump. While fluid pump (1110) is shown asbeing integrated within console (200), it should be understood thatfluid pump (1110) may alternatively be located external to console(200). Furthermore, it should be understood that fluid pump (1110) maybe coupled with various other components of console (200), including butnot limited to fluid reservoir (1000) (e.g., using fluid reservoir(1000) as a fluid source, etc.).

Tissue may be transported through tissue processing system (10) in avariety of ways. By way of example only, tissue may be transportedthrough at least part of tissue processing system (10) using a vacuum.In addition or in the alternative, tissue may be transported through atleast part of tissue processing system (10) using a fluid medium, suchas air, saline, a medical fluid component, etc. Such a fluid medium maybe pressurized or may be at atmospheric pressure (e.g., providing apressure differential relative to a vacuum, etc.). In addition or in thealternative, tissue may be transported through at least part of tissueprocessing system (10) using a pusher, an auger, a conveyor, and/or someother mechanical transport means. As yet another merely illustrativeexample, tissue may be transported through at least part of tissueprocessing system (10) using ultrasonic waves or acoustic pressure, suchas by activating one or more of the transducers that are describedherein as being used for other purposes. As still another merelyillustrative example, tissue may be transported through at least part oftissue processing system (10) using magnetic forces (e.g., interactingwith an additive in the medical fluid, etc.). It should also beunderstood that the method and/or apparatus for transporting tissuethrough tissue processing system (10) may vary based on the location orstage of the tissue within tissue processing system (10). Various othersuitable ways in which tissue may be transported through tissueprocessing system (10) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

III. Exemplary Tissue Harvesting Device

As shown in FIGS. 2-3, tissue harvesting device (100) of the presentexample comprises a body (102) and a needle (110) extending distallyfrom body (102). Needle (110) has a closed tissue piercing tip (112) anda transverse aperture (114) formed proximal to tip (112). A tubularcutter (not shown) is positioned within needle (110) and translateswithin needle (110) to sever tissue protruding through transverseaperture (114). A vacuum source (not shown) may be positioned withinbody (102) or external to body (102); and may communicate with needle(110) to draw tissue into transverse aperture (114) when needle (110) isinserted into a patient's tissue. Such a vacuum source may also assistin proximally transporting tissue specimens severed by the cutter to aregion within body (102). It should thus be understood that tissueharvesting device (100) may be configured in many ways like a biopsydevice. For instance, tissue harvesting device (100) may have variouscomponents that are configured and operable in accordance with aMAMMOTOME® biopsy device by Ethicon Endo-Surgery, Inc. of Cincinnati,Ohio and/or in accordance with the teachings of U.S. Pat. No. 5,526,822,entitled “Method and Apparatus for Automated Biopsy and Collection ofSoft Tissue,” issued Jun. 18, 1996; U.S. Pat. No. 6,086,544, entitled“Control Apparatus for an Automated Surgical Biopsy Device,” issued Jul.11, 2000; U.S. Pub. No. 2007/0118048, entitled “Remote Thumbwheel for aSurgical Biopsy Device,” published May 24, 2007; U.S. Pub. No.2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,”published Sep. 4, 2008; U.S. Non-Provisional patent application Ser. No.12/337,942, entitled “Biopsy Device with Central Thumbwheel,” filed Dec.18, 2008; and/or U.S. Non-Provisional patent application Ser. No.12/483,305, entitled “Tetherless Biopsy Device with Reusable Portion,”filed Jun. 12, 2009. The disclosure of each of the above-cited U.S.patents, U.S. Patent Application Publications, and U.S. Non-ProvisionalPatent Applications is incorporated by reference herein. Of course,tissue harvesting device (100) may have any other suitable components orconfigurations.

As best seen in FIG. 3, the underside of body (102) in the presentexample includes a pair of female ports (120, 121) and three recesses(130). Female ports (120, 121) are configured to mate with complementarymale ports (220, 221) of console (200); while docking recesses (130) areconfigured to mate with complementary mounting prongs (230) of console(200). Prongs (230) are configured to fit into recesses (130) andremovably secure tissue harvesting device (100) to console (200). Ofcourse, various other types of structures and features may be used toremovably secure tissue harvesting device (100) to console (200). By wayof example only, such securing features may include snap fits,over-center latches, magnets, clips, clamps, threaded members, etc.

As shown in FIGS. 4A-4B, port (120) includes a seal (122) and anassociated conduit (124). A guide chamfer (126) is positioned adjacentto port (120), and is configured to assist in guiding port (220) ofconsole (200) into port (120) of tissue harvesting device (100) astissue harvesting device (100) is coupled with console (200). As shownin FIG. 4B, seal (122) deforms as port (220) is inserted in port (120),allowing conduit (224) of port (220) to communicate with conduit (124)of port (120). Seal (122) also maintains a seal against port (220) asport (220) is inserted in port (120). In some versions, seal (122) lacksany slit or other type opening therethrough, such that port (220)pierces, tears, or otherwise breaks seal (122) upon insertion of port(220) in port (120). In some other versions, seal (122) includes apreformed slit or other type of feature that is configured to facilitateentry of port (220) through seal (122) while also substantially sealingconduit (124) when port (220) is not inserted in port (120). Seal (122)of the present example is further configured to substantially re-sealconduit (124) when port (220) is de-coupled from port (120).

It should be understood that tissue specimens may be communicated fromconduit (124) to conduit (224), such that tissue is transported fromtissue harvesting device (100) to console via ports (120, 220). Forinstance, conduit (124) may be in communication with the lumen of atubular cutter (not shown) and/or a tissue receptacle (not shown) oftissue harvesting device (100); while conduit (224) may be incommunication with tissue stirring chamber (300). In some versions,tissue harvesting device (100) performs at least some processing oftissue specimens before the tissue is communicated from port (120) toport (220). For instance, tissue harvesting device (100) may dice,mince, or otherwise reduce the size of tissue specimens obtained by atubular cutter of tissue harvesting device (100). In addition or in thealternative, tissue harvesting device (100) may mix tissue specimenswith a fluid, such that a tissue-fluid mixture is communicated from port(120) to port (220). It should also be understood that ports (121, 221)may have a configuration that is substantially identical to theconfiguration of ports (121, 221). Furthermore, ports (121, 221) may beused to communicate processed tissue, saline, and/or medical fluidcomponents from console (200) to tissue harvesting device (100). Forinstance, port (221) may be in communication with fluid removal chamber(800) and fluid pump (1110) of console (200); while port (121) mayultimately be in communication with needle (110).

To the extent that tissue harvesting device (100) is used to applyprocessed tissue and/or medical fluid components from console (200) to asite in a patient, needle (110) may be used in some versions. Forinstance, the processed tissue and/or medical fluid components may bedispensed through transverse aperture (114). In addition or in thealternative, a dispensing needle (150) may be used. Dispensing needle(150) of the present example has an open distal end (152). Body (102) isconfigured to selectively receive either type of needle (110, 150). Forinstance, needle (110) may be removed from body (102) an dispensingneedle (150) may then be coupled with body (102). Dispensing needle(150) may be used to administer processed tissue and/or medical fluidcomponents from console (200) to a site in a patient. In addition or inthe alternative, dispensing needle (150) may be used to depositprocessed tissue and/or medical fluid components from console (200) intoanother container. As yet another variation, a separate tissue therapydevice (101) may be coupled with console (200) in a manner similar totissue harvesting device (100). Tissue therapy device (101) may includea body (103) and a distally extending needle (111) having an open distalend (115) that is configured to dispense processed tissue and/or medicalfluid components at a target site in a patient. Still other suitablecomponents, features, configurations, and operabilities for tissueharvesting device (100) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

IV. Exemplary Tissue Processing Console

A. Overview

Tissue processing console (200) of the present example comprises ahousing (202) and a control panel (240) as shown in FIG. 5. Controlpanel (240) of this example includes a display (242), a plurality ofbuttons (244), and an input/output port (246). Display (242) is operableto render information to the user about the status of tissue processingsystem (10), such as whether processed tissue is ready for use, whichstage of the process tissue is in, what the tissue particle size is, howmany tissue particles there are, how much tissue had to be sent to wastechamber (700), how much fluid is in fluid reservoir (1000), etc. By wayof example only, display (242) may comprise a plurality of LEDs, atextual display, a graphical user interface, a touch screen interface,and/or a variety of other types of display technologies. Buttons (244)may comprise electromechanical switches, thin film switches, capacitiveswitches, and/or various other features configured to receive userinput. In some versions where display (242) comprises a touch screen,buttons (244) are omitted. Of course, buttons (244) may be omitted ifdesired, even if display (242) does not comprise a touch screen or evenif display (242) is also omitted. Input/output port (246) of the presentexample comprises a USB port, though any other suitable type ofinput/output port (246) may be used. Furthermore, it should beunderstood that console (200) may include a plurality of input/outputports (246) if desired; or even no input/output ports (246) if desired.In the present example, input/output port (246) may be coupled with akeyboard, mouse, flash drive, external hard drive, monitor, and/or acomputer. Thus, console (200) may receive data and/or commands, etc. viainput/output port (246). Similarly, console (200) may transmit dataand/or commands, etc. via input/output port (246).

Control panel (240) is in communication with control circuitry (250),which is shown in FIG. 6. Control circuitry (250) is also incommunication with various other components (300, 400, 500, 600, 800,1110) within console (200). In particular, control circuitry (250) isconfigured to control such components (300, 400, 500, 600, 800, 1110) inaccordance with user inputs via control panel (240) and/or in accordancewith predefined control algorithms or routines. It should be understoodthat control circuitry (250) may include various types of components,including but not limited to one or more processors and one or morememory devices. Various suitable ways in which control circuitry (250)may be configured will be apparent to those of ordinary skill in the artin view of the teachings herein.

B. Exemplary Coupling of Tissue Harvesting Device with Console

In the present example, and as noted above, console (200) is configuredto provide a saline flush of tissue harvesting device (100) when tissueharvesting device (100) is coupled with console (200). In particular,fluid pump (1110) is operable to force saline through ports (121, 221).Such flushing may urge tissue specimens from within tissue harvestingdevice (100) into tissue stirring chamber (300) via ports (120, 220).Saline that was forced through ports (121, 221) may likewise becommunicated back to console (200) via ports (120, 220). In someversions, such flushing is automatically provided as soon as tissueharvesting device (100) is coupled with console (200). For instance,tissue harvesting device (100) may be configured to actuate a trigger(e.g., mechanically, such as by pushing; electronically, such as by anRFID tag or EAS tag, etc) in console (200) as soon as tissue harvestingdevice (100) is coupled with console (200). Alternatively, console (200)may require a user to manually activate a button (244) or provide someother form of input in order to initiate a flushing cycle. It shouldalso be understood that a manual input for saline flush may be disableduntil tissue harvesting device (100) is coupled with console (200). Insome versions, tissue harvesting device (100) is configured tocommunicate information to console (200) (e.g., via wire, wirelessly,via metal contacts, etc.) indicating the total number of tissuespecimens and/or other tissue specimen information; and console (200)may automatically adjust the amount of saline communicated by fluid pump(1110) to provide a predefined solid/fluid ratio. As yet another merelyillustrative variation, fluid pump (1110) may be provided in tissueharvesting device (100) instead of being provided in console (200). Ofcourse, such saline flushing is merely optional, and may be modified oreven omitted as desired.

Once a desired amount of tissue specimens have been communicated fromtissue harvesting device (100) to console (200), tissue harvestingdevice (100) may be removed from console (200). Tissue harvesting device(100) may then be used to harvest additional tissue specimens.Alternatively, tissue harvesting device (100) may simply be set aside.As another alternative, tissue harvesting device (100) may remaincoupled with console (200) at this stage if desired. In still otherversions, some or all of the components and/or functionalities ofconsole (200) are integrated into tissue harvesting device (100), suchthat a separate console (200) lacks at least some such components or iseven omitted altogether.

C. Exemplary Stirring Chamber

As noted above, port (220) is in communication with a stirring chamber(300) in the present example. Stirring chamber (300) is operable to stirtissue communicated from tissue harvesting device (100) with a fluidmedium, such as saline and/or a medical fluid component, etc., todisperse the tissue within the fluid medium. A shown in FIG. 10,stirring chamber (300) comprises an input port (302), an output port(304), and a reservoir (306). A mixing blade (310) is positioned inreservoir (306), and is rotated by a corresponding motor (308) to mixtissue and a fluid medium within reservoir (306). Motor (308) may beselectively activated by control circuitry (250). While motor (308) andblade (310) are used to mix tissue and a fluid medium in the presentexample, it should be understood that various other structures andtechniques may be used to mix tissue and a fluid medium. For instance,motor (308) may rotate various other types of structures instead ofrotating a blade (310). As another variation, a solenoid or other typeof device may reciprocate an agitating member within reservoir (306). Asadditional merely illustrative variations, stirring chamber (300) mayuse ultrasonic vibration or electrohydrodynamics (EHD) to mix tissuewith a fluid medium. Other suitable ways in which stirring chamber (300)may mix tissue and a fluid medium will be apparent to those of ordinaryskill in the art in view of the teachings herein. Tissue and a fluidmedium may be held and mixed in reservoir (306) for any suitableduration. It should also be understood that one or more stirringchambers (300) may be located elsewhere in system (10), in addition toor in lieu of being located in the fluid path between tissue harvestingdevice and ultrasonic tissue measuring chamber (400). Of course, as withother components described herein, stirring chamber (300) may simply beomitted altogether if desired.

D. Exemplary Tissue Measuring Chamber

In the present example, after being stirred within stirring chamber(300), the tissue/fluid mixture is transmitted to ultrasonic tissuemeasuring chamber (400). An example of ultrasonic measuring chamber(400) is shown in FIG. 7. It should also be noted that FIG. 6 shows avariation in which port (220) is directly coupled with tissue measuringchamber (400), such that a separate stirring chamber (300) is omitted inthe version shown in FIG. 6. In the present example, tissue measuringchamber (400) comprises a housing (402) that defines a reservoir (404).A pair of input ports (406, 408) and three output ports (410, 412, 414)are in fluid communication with reservoir (404). Input port (406) isconfigured to communicate a tissue/fluid mixture from stirring chamber(300) into reservoir (404). Input port (408) is configured tocommunicate a tissue/fluid mixture from mincing chamber (500) intoreservoir (404). Output port (410) is configured to communicate tissuefrom reservoir (404) to waste chamber (700). Output port (412) isconfigured to communicate a tissue/fluid mixture from reservoir (404) tomincing chamber (500). Outlet port (414) is configured to communicatetissue from reservoir (404) to stimulation chamber (600). Examples ofthese types of communication to and from reservoir (404) will bedescribed in greater detail below.

Tissue measuring chamber (400) further comprises a drive transducer(416) and a receiving transducer (418). Drive transducer (416) issecured to fixed plunger (420), which is secured to housing (402).Receiving transducer (418) is secured to a movable plunger (422), whichis movable relative housing (402). In particular, movable plunger (422)is translatable along the axis defined by housing (402). It should beunderstood that plunger (420) may be movable relative to housing (402)in some versions, in addition to or in lieu of plunger (422) beingmovable relative to housing (402). In addition, it should be understoodthat plunger (422) may be fixed relative to housing (402) in someversions, in addition to or in lieu of plunger (420) being fixedrelative to housing (402). Transducers (416, 418) are each incommunication with control circuitry (250). Drive transducer (416) isconfigured to convert electrical energy into vibrational energy. Inparticular, drive transducer (416) is operable to generate ultrasonicenergy by vibrating at ultrasonic frequencies in response to controlsignals from control circuitry (250). For instance, drive transducer(416) may operate within parameters as taught in U.S. Pub. No.2009/0051350, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, drive transducer (416)may operate within parameters as taught in “Measuring Bubble, propandParticle Sizes in Multiphase Systems with Ultrasound” by Cents Brilmanand Versteeg (AIChE Journal, November 2004, Volume 50, Number 11, pp2750-2762), the disclosure of which is incorporated by reference herein.Alternatively, drive transducer (416) may operate at any other suitablefrequencies, amplitudes, and/or full resonant wavelengths, etc. Itshould also be understood that it may not be necessary for drivetransducer (416) to achieve resonance in all examples of use.

Drive transducer (416) may comprise an endmass, a plurality ofpiezoelectric discs, and a horn that is oriented toward reservoir (404).The piezoelectric discs may comprise lead zirconate titanate (PZT)and/or any other suitable material or combination of materials. The hornmay be formed of Ti64, though it should be understood that any othersuitable material(s) may be used. Electrical energy is provided to theendmass from control circuitry (250). This excites the piezo discs toproduce the ultrasonic vibrational energy, which is communicated to thehorn. The horn acoustically amplifies the ultrasonic wave, such that theconfiguration of the horn provides acoustic gain. An acoustic lens maybe included, if desired. It should be understood that, to the extentthat drive transducer (416) includes more than one piezoelectric element(e.g., crystals), such piezoelectric elements may be provided in anysuitable arrangement (e.g., stacked and/or arrayed, etc.). It shouldalso be understood that drive transducer (416) may be configured as adiagnostic transducer (e.g., relatively high frequency and relativelylow energy) rather than being configured as a power transducer (e.g.,relatively low frequency and relatively high energy), though a HIFU typeof transducer may be used if desired. By way of example only, drivetransducer (416) may be configured in accordance with the teachings ofany one or more of following, each of which is incorporated by referenceherein: U.S. Pub. No. 2008/0294054, entitled “Ultrasound Probe andDiagnostic Ultrasound System,” published Nov. 27, 2008; U.S. Pub. No.2009/0034370, entitled “Diagnostic Ultrasound Transducer,” publishedFeb. 5, 2009; U.S. Pat. No. 5,823,962, entitled “Ultrasound Transducerfor Diagnostic and Therapeutic Use,” issued Oct. 20, 1998; and/or U.S.Pat. No. 6,489,706, entitled “Medical Diagnostic Ultrasound Transducerand Method of Manufacture,” issued Dec. 3, 2002. Various other suitableways in which drive transducer (416) may be configured will be apparentto those of ordinary skill in the art in view of the teachings herein.

Receiving transducer (418) of the present example is essentiallyidentical in construction to drive transducer (416). Receivingtransducer (418) may thus be configured to absorb and sense ultrasonicenergy that is passed through the tissue/fluid mixture, with controlcircuitry (250) being configured to calculate the size of tissueparticles within reservoir (404) based at least in part on ultrasonicenergy absorbed by receiving transducer (418). Of course, receivingtransducer (418) may have any other suitable alternative configurationas will be apparent to those of ordinary skill in the art in view of theteachings herein. It should also be understood that receiving transducer(418) may even be omitted in some versions. For instance, receivingtransducer (418) may be omitted in some versions where measurement oftissue particle size is done through reflection, of the ultrasonicenergy. In some such versions, drive transducer (416) may be used tosense the reflected ultrasonic energy, with control circuitry (250)being configured to calculate the size of tissue particles withinreservoir (404) based at least in part on reflected ultrasonic energyabsorbed by drive transducer (416). Of course, tissue particle size mayalso be measured based on a combination of ultrasonic energy absorbed bydrive transducer (416) and receiving transducer (418); and/or in anyother suitable fashion.

In the present example, drive transducer (416) operates at parametersselected to de-aerate the tissue/fluid mixture in reservoir (404), suchthat drive transducer (416) removes entrained air from the tissue/fluidmixture. For instance, power applied to drive transducer (416) may beincreased to provide ultrasonic de-aeration in some settings. In someversions, housing (402) is configured or oriented such that reservoir(404) is oriented along a non-horizontal axis, allowing air to collectat a longitudinal end of reservoir (404) for subsequent removal (e.g.,by active withdrawal or passive venting, etc.). For instance, FIG. 9shows housing (402) oriented at a non-horizontal angle α. In addition,movable plunger (422) is moved within housing (402) in the presentexample to modify the volume of reservoir (404) based on the volume oftissue and/or fluid communicated through input (406) into reservoir(404). In addition, movable plunger (422) is movable to expose atissue/fluid mixture within reservoir (404) to an absorbent medium(430), which is configured to remove fluid from the tissue/fluid mixturein reservoir (404). Absorbent medium (430) may be formed of any suitablematerial, including but not limited to various paper compositions,cotton, various materials found in tampons or diapers, etc.Alternatively, absorbent medium (430) may be formed of any othersuitable material or combination of materials. In some versions, ratherthan moving plunger (422) to expose the tissue/fluid mixture toabsorbent medium (430) with plunger (420) staying in a fixed position,plungers (420, 422) move together relative to housing (402) to exposethe tissue/fluid mixture to absorbent medium (430). In other words,plungers (420, 422) may move together in some versions to essentiallyshift the location of reservoir (404) within housing without changingthe volume of reservoir (404) to expose the tissue/fluid mixture toabsorbent medium (430). In any case, movement of one or both of plungers(420, 422) may be accomplished in various ways, including but notlimited to using one or more drive motors, solenoids, pneumaticactuators, hydraulic actuators, etc.

Once the tissue/fluid mixture in reservoir (404) has been de-aerated,control circuitry (250) may begin to operate drive transducer (416) in asecond operational mode. In particular, control circuitry (250) mayactivate drive transducer (416) to emit ultrasonic energy configured tomeasure the size of tissue particles in the tissue/fluid mixture whendrive transducer (416) is operated in the second operational mode. Insome versions, such tissue particle size measurement may be provided inaccordance with the teachings of “Measuring Bubble, propand ParticleSizes in Multiphase Systems with Ultrasound” by Cents Brilman andVersteeg (AIChE Journal, November 2004, Volume 50, Number 11, pp2750-2762), the disclosure of which is incorporated by reference herein.For instance, control circuitry (250) may apply a drive signal to drivetransducer (416) to emit ultrasonic energy that passes through thetissue/fluid mixture and ultimately reaches receiving transducer (418).Such emissions by drive transducer (416) may include frequency sweepsand/or amplitude sweeps within any suitable range or ranges. Receivingtransducer (418) is also in communication with control circuitry (250),which includes a logic configured to process data obtained throughreceiving transducer (418). In particular, control circuitry (250) maymeasure the velocity profile and/or the attenuation profile of theultrasound energy received by receiving transducer (418), which may thenbe interpreted by control circuitry (250) to indicate the size of tissueparticles in reservoir (404). As another merely illustrative example,tissue measuring chamber (400) and control circuitry (250) may beconfigured to measure the size of tissue particles in reservoir (404) inaccordance with the teachings of U.S. Pub. No. 2009/0051350, entitled“Device and Process for Detecting Particles in a Flowing Liquid,”published Feb. 26, 2009, the disclosure of which is incorporated byreference herein. As yet another merely illustrative example, drivetransducer (416) and/or some other transducer positioned at the same endof reservoir (404) as drive transducer (416) may be configured toreceive ultrasonic pulses reflected back from tissue particles inreservoir (404), and signals indicative of such reflected pulses may beprocessed by control circuitry (250) to determine the tissue particlesize.

Regardless of how the tissue particle sizes are measured, controlcircuitry (250) may compare the measured tissue particle sizes to apredetermined size range to determine whether the size of tissueparticles in reservoir (404) falls within the predetermined size range.For instance, the predetermined size range may be between approximately0.5 mm³ and approximately 2 mm³; or more particularly betweenapproximately 0.5 mm³ and approximately 0.75 mm³. It should beunderstood that the predetermined size range may be a set rangeoriginally programmed in memory of control circuitry (250); or the sizerange may be established by a user by input through control panel (240).To the extent that console (200) allows a user to establish the sizerange, this may be provided in various ways. In some versions, controlpanel (240) allows a user to select a size range from variouspredetermined size ranges. In addition or in the alternative, controlpanel (240) may allow the user to manually input a customized sizerange. Various suitable tissue particle size ranges and methods forestablishing such ranges will be apparent to those of ordinary skill inthe art in view of the teachings herein.

As part of a routine of processing tissue particle measurements sensedby receiving transducer (418), sensed by drive transducer (416), and/orotherwise sensed, control circuitry (250) may also provide a process fortransferring tissue particles based on their size. For instance, in someversions, control circuitry (250) is configured to provide transmissionof tissue particles whose size is above the predetermined range fromtissue measuring chamber (400) to mincing chamber (500) via output port(412); to provide transmission of tissue particles whose size is belowthe predetermined range from tissue measuring chamber (400) to wastechamber (700) via output port (410); and to provide transmission oftissue particles whose size is within the predetermined range fromtissue measuring chamber (400) to stimulation chamber (600) via outletport (414). In some versions, such transmission is accomplished in partthrough activation of fluid pump (1100). In addition, it should beunderstood that each outlet port (410, 412, 414) may include arespective valve that is selectively opened by control circuitry (250),such as by activating a solenoid or other device associated with a givenvalve. Processing of tissue particles in mincing chamber (500) and instimulation chamber (600) will be described in greater detail below.Tissue particles that are transmitted from reservoir (404) to wastechamber (700) via output port (410) may simply be disposed of orotherwise dealt with.

In addition to or in lieu of using fluid pump (1100) to transmit tissueparticles from tissue measuring chamber (400) to mincing chamber (500),stimulation chamber (600), or waste chamber (700), drive transducer(416) may be used to transmit tissue particles. For instance, drivetransducer (416) may be tuned to create a DC force in tissue particlesand/or an acoustic pressure that is operable to drive tissue particlestoward one or more of output ports (410, 412, 414). In some versions,the tissue particles will move against or with the radiation force fromdrive transducer (416) based on the size of the tissue particles. Theradiation force may be controlled by amplitude and/or based on one ormore other operating parameters. The waveform may be pulsed to advancethe tissue particles from node to node in some versions. In addition orin the alternative, at least some degree of frequency modulation mayfacilitate movement of tissue particles.

In some versions, drive transducer (416) may be tuned and selectivelyactivated to move small tissue particles first (e.g., toward wastechamber (700)), then move large tissue particles second (e.g., towardmincing chamber (500)), then move medium sized tissue particles third(e.g., toward stimulation chamber (600)). For instance, ultrasonicenergy emitted at a first amplitude may move tissue particles whose sizeis less than a predetermined size range away from drive transducer (416)toward output port (410). Ultrasonic energy emitted at a secondamplitude (e.g., higher than the first amplitude) may move tissueparticles whose size falls within the predetermined size range away fromdrive transducer (416) toward output port (414). Ultrasonic energyemitted at a third amplitude (e.g., higher than the second amplitude)may move tissue particles whose size exceeds the predetermined sizerange away from drive transducer (416) toward output port (412). Drivetransducer (416) may successively cycle through all three amplitudes,operating at a particular amplitude (or within particular amplituderanges) for any suitable time period. By way of example only, drivetransducer (416) may be operated in accordance with the teachings of“Moving Particles with Ultrasonic Standing Waves” by Martin McDonnell(DSTL Codex Journal, Summer 2008, Issue 1, pp. 1-4), the disclosure ofwhich is incorporated by reference herein, to move tissue particles.Alternatively, drive transducer (416) may be used to move tissueparticles in any other suitable fashion, as will be apparent to those ofordinary skill in the art in view of the teachings herein.

It should also be understood that measuring chamber (400) may have onlyone output port in some versions. For instance, a routing apparatus (notshown) may be coupled with the single output port, and may route outputfrom measuring chamber (400) to a selected destination (e.g., mincingchamber (500), waste chamber (700), or stimulation chamber (600), etc.)based on instructions from control circuitry (250).

Before tissue particles are transferred from reservoir to mincingchamber (500), the tissue particles may be separated from their carrierfluid to some degree. In the present example, once it is determined thatreservoir (404) contains tissue particles that are within thepredetermined size range, plunger (422) is moved relative to housing toexpose absorbent medium (430) to the fluid carrier within reservoir(404). Absorbent medium (430) may then absorb at least some of the fluidcarrier. To assist in this process, plunger (420) may also move withinhousing (402) toward plunger (422), to compress the fluid carrier andthereby urge the fluid carrier into absorbent medium (430). To theextent that either plunger (420, 422) translates within housing (402),such translation may be to a predetermined position or to a positioncalculated by control circuitry (250) based on any suitable factor orfactors such as the volume of tissue/fluid introduced into reservoir(404), the final number of tissue particles or cells in reservoir (404),and/or based on any other suitable factor or combination of factors.With the fluid carrier being absorbed by absorbent medium (430), thetissue cells would remain within reservoir (404). If desired, theabsence of fluid in reservoir (404) may be sensed in various ways. Forinstance, the absence of fluid in reservoir (404) may be sensed based onthe pressure on either or both transducers (416, 418), based on thetorque on a motor used to push on one of transducers (416, 418), basedon backloading on a solenoid used to push one of transducers (416, 418),based on feedback from a capacitance sensor or other type ofhydrosensitive sensor, and/or in any other suitable fashion. It shouldalso be understood that any or all of output ports (410, 412, 414) maybe positioned near or adjacent to absorbent medium (430), which mayfacilitate communication of tissue through output ports (410, 412, 414)after fluid has been substantially removed from a tissue/fluid mixtureby absorbent medium (430). Furthermore, some fluid may be kept inreservoir (404) despite the use of absorbent medium (430), with suchresidual fluid being used to facilitate conveyance of tissue particlesto and through one or more of output ports (410, 412, 414). To theextent that all fluid has been removed from reservoir (404), tissueparticles may be conveyed to and through one or more of output ports(410, 412, 414) using a plunger and/or some other feature, structure,device, or technique, etc. In some versions, tissue is removed manuallyfrom reservoir (404) after the tissue has been separated from fluid,such as by opening a lid or retrieving the tissue through an accessport, etc.

In some other versions, the interior wall of housing (402) is lined withan absorbent medium (not shown), which is covered by a sleeve (notshown) during the process of measuring tissue particle size, etc. Onceit is determined that reservoir (404) contains tissue particles that arewithin the predetermined size range, the sleeve may be removed to exposethe absorbent medium to the fluid carrier. The absorbent medium may thenabsorb at least some of the fluid carrier. To the extent that theabsorbent medium is porous, the pore size of the absorbent medium may beselected to reduce or even avoid tissue particles getting stuck in thepores of the absorbent medium. As another merely illustrative example, atissue/fluid mixture may be passed through a screen or other type offilter that is configured to catch tissue particles while allowing thefluid to pass through. In some versions, regardless of how tissueparticle size is measured and regardless of how/whether fluid is removedafter particle size measurement, reservoir (404) may be flushed with afluid such as saline.

An exemplary alternative tissue measurement chamber (401) is shown inFIG. 8. In this example, an absorbent medium (431) at least partiallyencircles a receiving transducer (419). In addition, absorbent medium(431) forms part of plunger (423), which is movable relative to housing(403) in this example. A cover member (not shown) may selectively coverabsorbent medium (431) within the reservoir defined by housing (403).This cover member may be moved to expose absorbent medium (431) at theappropriate time, to allow absorbent medium (431) to absorb at leastsome of the fluid carrier in the reservoir. A relief mechanism (425) isalso provided in plunger (423) in this example. Relief mechanism (425)is operable to prevent material from leaking out of tissue measurementchamber (401) until relief mechanism (425) is opened to allow fluid tobe drained from tissue measurement chamber (401). In some versions,relief mechanism (425) is used to remove substantially all of the fluid,while absorbent medium (431) is used to soak up any remaining fluid.Tissue measurement chamber (401) may otherwise be configured like tissuemeasurement chamber (400) as described above; or may have any othersuitable configuration.

Another exemplary alternative tissue measurement chamber (450) is shownin FIG. 11. In this example, tissue measuring chamber (450) comprises ahousing (452) defining a reservoir (454). A drive transducer (456) ispositioned at one end of housing (452). A sinusoidal signal (458) isapplied to drive transducer (456) to create an acoustic pressure (460)that drives solid cellular material (462) toward the opposite end ofreservoir (454). This opposite end of reservoir (454) may include asolid reflecting or absorbing surface (464). In some versions, thesinusoidal signal (458) is continuous. As another example, thesinusoidal signal (458) may be pulsed. As yet another example, thesinusoidal signal (458) may be frequency modulated. As still anotherexample, the sinusoidal signal (458) may be amplitude modulated. Ofcourse, the sinusoidal signal (458) may have any suitable combination ofsuch properties, if desired. Solid cellular material (462) that is sizedwithin the selected tissue particle material range is then communicatedthrough output port (466) and is further processed in accordance withthe teachings herein. It should therefore be understood that tissuemeasurement chamber (450) may have other components, features, andoperabilities as described above in the context of tissue measurementchamber (400) and/or tissue measurement chamber (401).

In some versions, a single chamber is used to both stir a tissue/fluidmixture and perform ultrasonic tissue measuring. For instance, the sameultrasonic field that de-aerates a tissue/fluid mixture may alsoeffectively stir the tissue/fluid mixture. As another merelyillustrative example, drive transducer (416) may be activated to emit aquick pulse of high intensity ultrasound to help mix tissue particles ina fluid solution. Thus, it should be understood that components,features, and/or functionalities of stirring chamber (300) may beincorporated into ultrasonic tissue measuring chamber (400). Similarly,components, features, and/or functionalities of ultrasonic tissuemeasuring chamber (400) may be incorporated into tissue stirring chamber(300). Various suitable ways in which such integration may beaccomplished will be apparent to those of ordinary skill in the art inview of the teachings herein.

While tissue measuring chamber (400) uses ultrasound to measure tissueparticle sizes, it should be understood that various other types ofmethods may be used to measure tissue particle sizes. By way of exampleonly, tissue measuring chamber (400) may use an electric field, laserdiffraction, and/or various other techniques to detect tissue particlesize as will be apparent to those of ordinary skill in the art in viewof the teachings herein. It should also be understood that, with anunderstanding of tissue particle size as sensed by tissue measuringchamber (400), and with an understanding of the total volume of tissue(e.g., based on location of plungers (420, 422), the total number oftissue particles may be estimated, if desired.

E. Exemplary Tissue Mincing Chamber

The following discussion will be provided in the context of tissuemeasuring chamber (400), though it should be understood that thefollowing may equally apply in versions where tissue measuring chamberis substituted with tissue measuring chamber (401) or tissue measuringchamber (450). As noted above, upon processing tissue particlemeasurements sensed by receiving transducer (418) or otherwise sensed,control circuitry (250) is configured to provide transmission of tissueparticles whose size is above the predetermined range from reservoir(404) to mincing chamber (500) via output port (412). As shown in FIG.6, output (412) of measuring chamber (400) is coupled with mincingchamber (500) via a tube (440); while input (408) of measuring chamber(400) is coupled with mincing chamber (500) via a tube (442). Of course,chambers (400, 500) may be in fluid communication with each other in anyother suitable fashion.

Mincing chamber (500) is operable to mince the tissue particles intosmaller pieces; then transmit the minced tissue particles back toreservoir via input port (408). Mincing chamber (500) may includevarious types of components that are operable to mince tissue particles.By way of example only, mincing chamber (500) may include one or moremovable mincing blades, one or more mincing screens or grids, one ormore grinding wheels, one or more ultrasonic mincing transducers, and/orany other suitable components, features, or devices that are operable tomince tissue particles. In some versions where mincing chamber (500)ultrasonically minces tissue, mincing chamber (500) may include a sieveor other type of structure that vibrates ultrasonically, such thattissue is minced as it passes through the sieve or other type ofvibrating structure. By way of example only, an ultrasonic mincing sievemay comprise three to five parallel blades that ultrasonically vibratesimultaneously. Other suitable ways in which an ultrasonic sieve orother type of ultrasonic mincing device may be configured will beapparent to those of ordinary skill in the art in view of the teachingsherein. To the extent that mincing chamber (500) includes one or moremincing members that are subject to selective activation, it should beunderstood that control circuitry (250) may be configured to providesuch selective activation. As another merely illustrative example,mincing chamber (500) may include a manually movable mincing member,such that the mincing member is actuated by a user manually manipulatinga handle, crank, dial, or other type of manual driving input.

In some versions, the data indicating the size of tissue particlesmeasured in reservoir (404) is used to influence operation of mincingchamber (500). That is, control circuitry (250) may select a lengthand/or intensity of time tissue spends in mincing chamber (500) based onthe size of the tissue particles that was originally measured inreservoir (404). For instance, if control circuitry (250) determinesthat tissue particles in reservoir (404) are significantly larger insize than the acceptable size range, control circuitry (250) mayactivate mincing chamber (500) to mince the tissue for a significantlength of time and/or at a significantly high intensity. If controlcircuitry (250) determines that tissue particles in reservoir (404) areslightly larger in size than the acceptable size range, controlcircuitry (250) may activate mincing chamber (500) to mince the tissuefor a relatively short length of time and/or at a relatively lowintensity. Other various ways in which the measured size of tissueparticles may be used to influence operation of mincing chamber (500)will be apparent to those of ordinary skill in the art in view of theteachings herein.

Once mincing chamber (500) has completed at least one cycle of mincingtissue, the minced tissue may be communicated back to measuring chamber(400) via input port (408). As with other instances of tissue transportdescribed herein, such transmission may be carried out using fluid pump(1100) and/or various other types of transport means. Similarly, a valveat port (408) may be selectively opened while a valve at port (412) maybe selectively closed when tissue is transmitted from mincing chamber(500) back to measuring chamber (400). In some other versions, a singleport provides bi-directional communication between chambers (400, 500).Once the minced tissue reaches reservoir (404), measuring chamber (400)and control circuitry (250) may then re-measure the minced tissue andcompare the minced tissue particle size to the predetermined size rangeas described above. Based on this comparison, the minced tissue may befurther processed as described above. It should therefore be understoodthat tissue may be recycled through mincing chamber (500) as many timesas needed until the tissue particles reach a size falling within thepredetermined range.

It should be noted that a mincing chamber (500) may be located“upstream” of measuring chamber (400) in some versions, if desired,particularly if tissue harvesting device (100) is configured to obtainrelatively large tissue specimens that are expected to initially belarger than the predetermined size range. Such an upstream mincingchamber (500) may be provided in addition to or in lieu of a mincingchamber (500) that receives tissue after the tissue passes throughmeasuring chamber (400) as described above. It should also be understoodthat, in versions where a mincing chamber (500) is provided upstream ofa measuring chamber (400), tissue may be communicated back to mincingchamber (500) from measuring chamber (400) in the event that the tissueparticles are found to exceed the predetermined size range as describedabove.

It should also be understood that a single chamber may be used toperform both ultrasonic tissue measuring and tissue mincing (ultrasonicor otherwise) in some versions. Thus, it should be understood thatcomponents, features, and/or functionalities of ultrasonic tissuemeasuring chamber (400) may be incorporated into tissue mincing chamber(500). Likewise, components, features, and/or functionalities of tissuemincing chamber (500) may be incorporated into ultrasonic tissuemeasuring chamber (400). Various suitable ways in which such integrationmay be accomplished will be apparent to those of ordinary skill in theart in view of the teachings herein. Similarly, various other suitableways in which tissue mincing chamber (500) may be configured anoperated, regardless of whether tissue mincing chamber (500) and tissuemeasuring chamber (400) are combined, will be apparent to those ofordinary skill in the art in view of the teachings herein.

F. Exemplary Tissue Stimulation Chamber

As noted above, upon processing tissue particle measurements sensed byreceiving transducer (418) or otherwise sensed, control circuitry (250)is configured to provide transmission of tissue particles whose size iswithin the predetermined range from reservoir (404) to stimulationchamber (600) via output port (414). Stimulation chamber (600) isoperable to electrically stimulate the tissue particles. In someversions, stimulation chamber (600) is formed at least in part ofpoly(dimethylsiloxane) (PDMS) on glass. Of course, any other suitablematerial or combination of materials may be used. Also in some versions,stimulation chamber (600) is formed using a combined process includingstereolithography and mold curing, though it should be understood thatany other suitable process or combination of processes may be used.While stimulation chamber (600) of the present example comprises justone chamber or well for stimulating tissue, it should be understood thatstimulation chamber (600) may have any other suitable number of chambersor wells (e.g., two, four, etc.) provided in an array or in any othersuitable configuration. Stimulation chamber (600) includes a pair ofinterior electrodes (not shown), which are provided at opposite sides ofeach inner chamber or well defined by stimulation chamber (600). Controlcircuitry (250) is operable to activate the electrodes to provideelectrical stimulation to tissue cells that are introduced intostimulation chamber (600). Such electrical stimulation may increase theeffectiveness of tissue cells in their subsequent use. For instance,electrical stimulation may increase stem cell activity. It should alsobe understood that the current used to keep the voltage in stimulationchamber (600) substantially constant could also be used as a means toapproximate the total mass of cells within stimulation chamber (600).

As another merely illustrative example, control circuitry (250) may beconfigured to stimulate the electrodes of stimulation chamber (600) withsquare wave electric pulses or in any other suitable fashion (e.g., withsawtooth waveform, sinusoidal waveform, etc.). Other various suitablecomponents, features, configurations, and operabilities that may beassociated with stimulation chamber (600) will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that functionality of stimulation chamber (600) maybe integrated into tissue measurement chamber (400) and/or into othercomponents of system (10), if desired. In other words, it should beunderstood that tissue cells may be ultrasonically stimulated. Varioussuitable ways in which such functionality may be integrated into tissuemeasurement chamber (400) and/or into other components of system (10)will also be apparent to those of ordinary skill in the art in view ofthe teachings herein.

G. Exemplary Fluid Removal Chamber

After being stimulated in stimulation chamber (600), tissue iscommunicated to fluid removal chamber (800) in the present example. Asshown in FIG. 12, fluid removal chamber (800) comprises a housing (802)that is in fluid communication with an input fluid conduit (804) and anoutput fluid conduit (806). Housing (802) includes a top portion (808),a bottom portion (810), and a side portion (812) that extends betweentop portion (808) and bottom portion (810). Top portion (808) and bottomportion (810) each include an electrically conductive material (e.g., ametal, etc.). Side portion (812) is formed of a non-conductive material(e.g., a plastic, etc.). An electrically conductive filter screen (814)is positioned within housing (802), between top portion (808) and bottomportion (810). A DC bias current (816) is applied to top portion (808),bottom portion (810), and filter screen (814), with filter screen (814)having a positive polarity and top and bottom portions (808, 810) havingnegative polarity. In some versions, due to the polar nature of cellularmaterial, such cellular material within housing (802) may tend toagglomerate around filter screen (814), allowing liquid to be removedthrough output fluid conduit (806).

Fluid removed through output fluid conduit (806) is communicated tofluid reservoir (1000) in the present example. In some versions, suchfluid communicated to fluid reservoir (1000) is used in tissue stirringchamber (300), as described above, in subsequent tissue processingcycles. In addition or in the alternative, such fluid in fluid reservoir(1000) may be driven by fluid pump (1100) to flush harvested tissue fromtissue harvesting device (100), as described above, in subsequent tissueprocessing cycles. In some other versions, fluid removed through outputfluid conduit (806) is simply disposed of Of course, fluid removedthrough output fluid conduit (806) may be dealt with in any othersuitable fashion. In the present example, fluid reservoir (1000)comprises a chamber that is integral within console (200). In some otherversions, fluid reservoir (1000) comprises a canister that is removablycoupled with console (200) via mating self-sealing ports, via a conduitextending from console (200), or by some other means of coupling. Instill other versions, fluid reservoir (1000) is either incorporated intoone or more other components of console (200) or is simply omittedaltogether.

After fluid is removed by fluid removal chamber (800), the tissue may becommunicated to various other locations. For instance, the tissue may becommunicated to port (221), through which the tissue may be furthercommunicated to tissue harvesting device (100) and/or to tissue therapydevice (101) for administration of the tissue to a patient (e.g., aspart of a medical fluid). In some such versions, console (200) alsoincludes a medical fluid chamber (not shown) positioned between fluidremoval chamber (800) and port (221). Such a medical fluid chamber mayinclude one or more medical fluid components that may be combined withprocessed tissue and communicated with the processed tissue to tissueharvesting device (100) and/or to tissue therapy device (101) foradministration of the medical fluid mixture to a patient. In addition orin the alternative, a medical fluid chamber may be positioned betweenconsole (200) and tissue harvesting device (100) or tissue therapydevice (101), such that the processed tissue from console (200) is mixedwith the medical fluid on its way to tissue harvesting device (100) ortissue therapy device (101). As yet another variation, a medical fluidchamber may be provided within tissue harvesting device (100) and/or totissue therapy device (101), such that the processed tissue from console(200) is mixed with the medical fluid once it reaches tissue harvestingdevice (100) or tissue therapy device (101).

As another merely illustrative example, tissue may be communicated fromfluid removal chamber (800) to a tissue container (900). Such a tissuecontainer (900) may comprise a chamber that is integral within console(200). In some other versions, tissue container (900) comprises acanister that is removably coupled with console via mating self-sealingports, via a conduit extending from console (200), or by some othermeans of coupling. At least some tissue may be communicated from fluidremoval chamber (800) to waste chamber (700), if desired. Still othersuitable ways in which tissue from fluid removal chamber (800) may behandled, including but not limited to other components or devices towhich such tissue may be communicated, will be apparent to those ofordinary skill in the art in view of the teachings herein.

In some versions, filter screen (814) is removable from housing (802).In particular, filter screen (814) may be removable so that once tissueis fully agglomerated to filter screen (814), filter screen (814) andagglomerated tissue may be removed for further processing. In additionor in the alternative, fluid removal chamber (800) may include a scraperdevice (not shown) that is operable to at least substantially removetissue from filter screen (814). For instance, such a scraper device maycomprise a rotating scraper that is operable to scrape cells/tissue fromfilter screen (814) and convey the scraped cells/tissue into a centralcore at the axis of the scraper. The scraped cells/tissue may then betransmitted to waste chamber (700), tissue container (900), tissueharvesting device (100) and/or tissue therapy device (101) using aplunger, using a relatively small amount of saline or other fluid toflush the cells/tissue, using any other means of conveyance referred toherein, or in any other suitable fashion.

It should also be understood that the screening and removal of fluid maybe provided within tissue harvesting device (100) and/or tissue therapydevice (101), in addition to or in lieu of being provided within console(200). For instance, fluid removal chamber (800) (or some variationthereof) may be incorporated into tissue harvesting device (100) and/ortissue therapy device (101); and may be used after processed tissue iscommunicated from console (200) to tissue harvesting device (100) and/ortissue therapy device (101). Of course, fluid removal chamber (800) asdescribed above is only one example of how fluid may be removed fromtissue. It should be understood that one or more other components ofconsole (200) may remove fluid from tissue, including but not limited totissue measuring chamber (400, 401, 450). To the extent that a fluidremoval chamber (800) is included as a part of console (200), othersuitable components, features, configurations, and operabilities offluid removal chamber (800) will be apparent to those of ordinary skillin the art in view of the teachings herein.

H. Exemplary Control Logic

As noted above, control circuitry (250) of the present example isconfigured to control various components (300, 400, 500, 600, 800, 1110)in accordance with user inputs via control panel (240) and/or inaccordance with predefined control algorithms or routines. It shouldalso be understood that console (200) may include various sensors (notshown) in communication with control circuitry (250), and that variousconditions detected by such sensors may trigger various types ofresponses from control logic in control circuitry (250). By way ofexample only, a sensor may be configured to detect the coupling oftissue harvesting device (100) with console (200), and may be furtherconfigured to communicate data indicative of the same to controlcircuitry (250). Various suitable ways in which such a sensor may beconfigured and positioned will be apparent to those of ordinary skill inthe art in view of the teachings herein. In addition, a sensor may beconfigured to detect the presence of tissue within measuring chamber(400), and may be further configured to communicate data indicative ofthe same to control circuitry (250). By way of example only, such asensor may be provided by drive transducer (416). Alternatively, someother sensor may be used to detect the presence of tissue withinmeasuring chamber (400) while drive transducer (416) is then used tomeasure the size of tissue particles within measuring chamber (400).Various other suitable ways in which such a sensor may be configured andpositioned will be apparent to those of ordinary skill in the art inview of the teachings herein.

In addition, a sensor may be configured to detect the presence of tissuewithin mincing chamber (500), and may be further configured tocommunicate data indicative of the same to control circuitry (250).Various suitable ways in which such a sensor may be configured andpositioned will be apparent to those of ordinary skill in the art inview of the teachings herein. A sensor may also be configured to detectthe presence of tissue within fluid removal chamber (800), and may befurther configured to communicate data indicative of the same to controlcircuitry (250). Various suitable ways in which such a sensor may beconfigured and positioned will also be apparent to those of ordinaryskill in the art in view of the teachings herein. In addition, a sensormay be configured to detect the level of fluid within fluid reservoir(1000) (e.g., when fluid reservoir (1000) is empty), and may be furtherconfigured to communicate data indicative of the same to controlcircuitry (250). Various suitable ways in which such a sensor may beconfigured and positioned will also be apparent to those of ordinaryskill in the art in view of the teachings herein. In addition, a sensormay be configured to detect an amount of waste in waste chamber (700)(e.g., when waste chamber (700) is full), and may be further configuredto communicate data indicative of the same to control circuitry (250).Various suitable ways in which such a sensor may be configured andpositioned will also be apparent to those of ordinary skill in the artin view of the teachings herein. Of course, various other types ofsensors may be provided in various other locations within tissueprocessing system (10), and such sensors may detect a variety ofconditions. Various ways in which such additional/alternative sensorsmay be incorporated into tissue processing system (10) will be apparentto those of ordinary skill in the art in view of the teachings herein.

It should be understood that logic in control circuitry (250) may reactin a variety of ways in response to conditions detected by sensorswithin tissue processing system (10). The below table illustratesseveral merely illustrative examples of operational responses that logicin control circuitry (250) may provide based on one or more conditionsdetected by sensors in tissue processing system (10).

Condition Sensed Action(s) Taken Tissue harvesting device Liquid (e.g.,saline) flushed through tissue (100) coupled with harvesting device(100) into tissue stirring console (200) chamber (300) and/ormeasurement chamber (400). Tissue present in Activate measuring chamber(400) to de- measuring aerate tissue/fluid mixture. chamber (400)Activate measuring chamber (400) to measure tissue particle size.Transfer oversized tissue particles to mincing chamber (500). Tissuepresent in Activate mincing chamber (500) to mince mincing chamber (500)tissue. Transfer minced tissue back to measuring chamber (400). Transferappropriately sized tissue to stimulation chamber (600) and/or fluidremoval chamber (800). Tissue present in fluid Activate DC bias in fluidremoval chamber removal chamber (800) (800). Measure tissue particlemass. Transfer tissue to tissue harvesting device (100) and/or tissuetherapy device (101). Fluid reservoir (1000) at Activate alert ondisplay (242). or near empty Waste chamber (700) Activate alert ondisplay (242). at or near full

Still other suitable operational responses (or other types of responses)that logic in control circuitry (250) may provide based on one or moreconditions detected by sensors in tissue processing system (10) will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, various other types of conditions that may be sensedby sensors to trigger responses by control circuitry (250) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

V. Miscellaneous

As shown in FIGS. 2 and 5, waste chamber (700), tissue container (900)(not shown in FIG. 5), and fluid reservoir (1000) each comprise acanister in the present example; and are all located external to housing(202) of console (200). These components (700, 900, 1000) are insteadexternally coupled with a base (204) at the side of housing (202). Inparticular, these components (700, 900, 1000) and base (204) allcomprise respective ports that are configured to provide fluidcommunication between these components (700, 900, 1000) and console(200) when these components (700, 900, 1000) are coupled with base(204); and that are further configured to provide a substantially fluidtight seal when these components (700, 900, 1000) are de-coupled frombase (204). Such ports may thus be configured similar to ports (120,121, 220, 221) described above or be otherwise configured.

Positioning these components (700, 900, 1000) external to housing (202)may facilitate removal of these components (700, 900, 1000) for emptyingof these components (700, 900, 1000) and/or for replacement of thesecomponents (700, 900, 1000). It should be understood that each of thesecomponents (700, 900, 1000) may include a cap, a septum, and/or someother type of seal that can be used to prevent fluid leakage fromcomponents (700, 900, 1000) when any of these components (700, 900,1000) are removed from base (204). In addition or in the alternative,each port on base (204) associated with components (700, 900, 1000) mayinclude a cap, a septum, and/or some other type of seal that can be usedto prevent fluid leakage from base (204) when any of these components(700, 900, 1000) are removed from base (204).

While several devices and components thereof have been discussed indetail above, it should be understood that the components, features,configurations, and methods of using the devices discussed are notlimited to the contexts provided above. In particular, components,features, configurations, and methods of use described in the context ofone of the devices may be incorporated into any of the other devices.Furthermore, not limited to the further description provided below,additional and alternative suitable components, features,configurations, and methods of using the devices, as well as variousways in which the teachings herein may be combined and interchanged,will be apparent to those of ordinary skill in the art in view of theteachings herein.

Versions of the devices described above may be actuated mechanically orelectromechanically (e.g., using one or more electrical motors,solenoids, etc.). However, other actuation modes may be suitable as wellincluding but not limited to pneumatic and/or hydraulic actuation, etc.Various suitable ways in which such alternative forms of actuation maybe provided in a device as described above will be apparent to those ofordinary skill in the art in view of the teachings herein.

Versions of the devices described above may have various types ofconstruction. By way of example only, any of the devices describedherein, or components thereof may be constructed from suitable metals,ceramics, plastics, or combinations thereof. Furthermore, although notrequired, the construction of devices described herein may be configuredto be compatible with or optimize their use with various imagingtechnologies. For instance, a device configured for use with MRI may beconstructed from all non-ferromagnetic materials. Also for instance,when using optional imaging technologies with devices described herein,certain configurations may include modifications to materials ofconstruction such that portions or the device may readily appear in aresultant image. Various suitable ways in which these and othermodifications to the construction of devices described herein may becarried out will be apparent to those of ordinary skill in the art inview of the teachings herein.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures.

Versions of described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a userimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various versions in the present disclosure,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by those of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. A device for separating tissue particles, wherein thedevice comprises: (a) a first reservoir configured to receive tissueparticles in a fluid; (b) an ultrasonic transducer in communication withthe first reservoir, wherein the ultrasonic transducer is operable toemit ultrasonic energy toward tissue particles in the first reservoir;(c) control circuitry in communication with the ultrasonic transducer,wherein the control circuitry is configured to drive the ultrasonictransducer at parameters selected to provide movement of tissueparticles in the first reservoir based on the size of the tissueparticles, and (d) a screen, wherein the screen is configured toseparate tissue particles from fluid, wherein the screen is electricallydriven, wherein the control circuitry is operable to selectivelyactivate the electrically driven screen to separate tissue particlesfrom fluid.
 2. The device of claim 1, wherein the first reservoircontains a first set of tissue particles falling within a first sizerange, a second set of tissue particles falling within a second sizerange, and a third set of tissue particles falling within a third sizerange.
 3. The device of claim 2, wherein the control circuitry isconfigured to selectively drive the ultrasonic transducer at a first setof parameters associated with the first size range, at a second set ofparameters associated with the second size range, and at a third set ofparameters associated with the third size range.
 4. The device of claim3, wherein the control circuitry is configured to successively drive theultrasonic transducer at the first set of parameters for a first timeperiod, then at the second set of parameters for a second time period,then at the third set of parameters for a third time period.
 5. Thedevice of claim 1, wherein the reservoir includes a fluid output,wherein the ultrasonic transducer is configured to move tissue particlesin the first reservoir toward the fluid output.
 6. The device of claim5, wherein the control circuitry is configured to drive the ultrasonictransducer at parameters selected to provide movement of tissueparticles in the first reservoir toward the fluid output based on thesize of the tissue particles.
 7. The device of claim 1, wherein thewherein the control circuitry is configured to drive the ultrasonictransducer to emit ultrasonic energy in pulses.
 8. The device of claim1, wherein the wherein the control circuitry is configured to drive theultrasonic transducer to emit ultrasonic energy with frequencymodulation.
 9. The device of claim 1, further comprising a secondreservoir, wherein the second reservoir is downstream of the firstreservoir.
 10. The device of claim 9, wherein the screen is located inthe second reservoir.
 11. The device of claim 10, wherein the secondreservoir has a top portion, a bottom portion, and a side portion,wherein the top portion, the bottom portion, and the screen eachcomprise electrical conductors, wherein the side portion is anelectrical insulator.
 12. The device of claim 1, further comprising amincing member.
 13. The device of claim 12, wherein the mincing memberis in communication with the control circuitry.
 14. The device of claim13, wherein the mincing member comprises an ultrasonic member operableto vibrate at one or more ultrasonic frequencies to mince tissue. 15.The device of claim 12, further comprising a second reservoir, whereinthe mincing member is located in the second reservoir.
 16. A device forseparating tissue particles, wherein the device comprises: (a) a firstreservoir configured to receive tissue particles in a fluid; (b) anultrasonic transducer in communication with the first reservoir, whereinthe ultrasonic transducer is operable to emit ultrasonic energy towardtissue particles in the first reservoir, and wherein the ultrasonictransducer is operable to receive ultrasonic energy returned by thetissue particles; and (c) control circuitry in communication with theultrasonic transducer, wherein the control circuitry is configured todrive the ultrasonic transducer at parameters selected to measure thesize of the tissue particles based on the ultrasonic energy received bythe ultrasonic transducer and to provide movement of tissue particles inthe first reservoir based on the size of the tissue particles.
 17. Thedevice of claim 16, wherein the first reservoir contains a first set oftissue particles falling within a first size range, a second set oftissue particles falling within a second size range, and a third set oftissue particles falling within a third size range, and wherein thecontrol circuitry is configured to selectively drive the ultrasonictransducer at a first set of parameters associated with the first sizerange, at a second set of parameters associated with the second sizerange, and at a third set of parameters associated with the third sizerange.
 18. The device of claim 17, wherein the control circuitry isconfigured to successively drive the ultrasonic transducer at the firstset of parameters for a first time period, then at the second set ofparameters for a second time period, then at the third set of parametersfor a third time period.